Safety and Standards

Manufacturing Certificate

Our partner, Winmate Inc. achieved ISO 13485:2003 and EN ISO 13485:2012 certification for it's design, development, production, installation, and servicing of medical devices. What does this mean for you? Winmate's certification confirms any portable panel PCs and mobile tablets we develop for use in the medical industry are safe and meet all regulatory design requirements.

This achievement will also enable Winmate to expand its medical-related product line, and create new opportunities for our original design manufacturer (ODM), original equipment manufacturer (OEM), and rebranding partners.

ISO 13485 is a quality management system standard specifically for the medical devices industry. It was written to support medical device manufacturers in designing quality management system that establish and maintain the effectiveness of their processes. It ensures consistency from design to delivery of medical devices, and confirms they are safe for use for their intended purpose.

Product Certificate

IEC 60601 is a standard published by the International Electro technical Commission. The standard consists of four parts, those being the base standard 60601-1 (general requirements for electrical medical equipment), collateral standards numbered 60601-1-X (example: IEC 60601-1-2, is a standard for Electromagnetic Disturbance – Requirements and tests), particular standards numbered 60601-2-X (example: IEC 60601-2-2, is the standard for high-frequency surgical devices), and performance standards in the 60601-3-X range. Winmate, has an entire line of IEC 60601-1, EN 60601-1:2006 + A1:2013, as well as UL 60601-1 CSA C22.2 certified Point of Care and Display. Winmate offers medical certified solutions for maintaining safe operations and collecting detailed, sensitive data in Operating Room and Hospital environments.